Preparatory Work for an Austrian Health Economic Guideline

Duration: February 2025 – January 2026
Language: English (with German summary)

Background:
In 2023, the Austrian government established an appraisal board (“Bewertungsboard für ausgewählte Arzneimittel”) under § 62d ff of the Federal Hospitals Act to ensure fair and rapid access to selected high-cost and specialised medicines used in hospitals and at the intersection between hospital and outpatient care, as well as to promote a nationally consistent use [1]. Health Technology Assessments (HTAs) support the board’s reimbursement decisions, contributing to evidence-based decision-making and greater transparency. In addition to evaluating effectiveness, safety, and other factors such as ethical and social impacts, health-economic evidence such as health economic evaluation (HEE) is a core component of these HTAs. In addition, HEEs may be required for healthcare interventions beyond drugs, including new developments such as artificial intelligence (AI) or complex public health interventions. HEE methods may differ from those used for drugs [2].

To improve the harmonisation and comparability as well as the quality of HEEs for healthcare interventions, many countries have developed and adopted health economic evaluation guidelines (HEEGs). These guidelines are widely used in Europe, Australia, North America [3-5]and low- and middle-income countries [6, 7]. Alongside other health systems guidance, such as clinical guidelines (CGs), HEEGs support evidence-based decision-making by ensuring adequate methods [8]. However, Austria has no formal publicly endorsed guideline with detailed specifications [9, 10]. Although a private industry consulting institute has addressed some methodological issues in a consensus document [11], it lacks precise methodological direction, and its use remains optional, serving as a recommendation rather than a requirement [9, 10].

Developing a HEEG requires a well-defined process. This process must consider potential barriers and facilitators, including the involvement of stakeholders [12, 13]. While Health System Guidance (HSG) documents, including standards and frameworks, are available for the development, dissemination, implementation and sustainment (DDIS) of CGs [14-21]or HTA guidelines [22, 23], no formal and systematic equivalents currently exist for HEEGs. There are only descriptive overviews of HEEG development processes in some countries [7, 24-27]and frameworks for evaluating and using health economic evidence in decision-making [28-31]. The methodological approach used and developed by Daccache et al. [2024] to accompany the guideline development process in Lebanon, which is based on the WHO approach HSGs [33, 34], comes closest to a DDIS process framework [32]. A clear and traceable DDIS process is crucial not only to ensure the transparency, objectivity, and effective use of such guidelines by research institutions, the pharmaceutical industry, or medical device companies but also to incorporate evidence from HEEs to inform reimbursement decisions, as required in many countries worldwide [6, 35-37].

Additionally, developing a HEEG requires an overview of existing international guidelines, the domains that existing guidelines address and methodological details. Several reviews already exist regarding guideline overviews [3-5, 7]. However, some recently developed and revised guidelines are not part of such reviews (e.g., Dutch and Slovak guideline) [38, 39]. Furthermore, guidelines for non-drug technologies (e.g., complex interventions) are usually not part of such reviews [2, 40].

Against this backdrop, and to strengthen the role of standardised HEEs in decision-making in Austria, scientific support for the DDIS process of a HEEG and its content is essential.

Purpose and Objectives
The primary purpose of this preparatory work is

a)     to obtain an overview of international guideline development processes and to derive options for such a process in Austria

b)     Identify barriers and facilitators of the HEEG’s DDIS process: Explore potential challenges and enablers in its development, dissemination, implementation, and sustainment to ensure effective adoption and use.

c)     to obtain an overview of international HEEG, their contents and specific methodological suggestions for different parts of economic evaluations

Research Questions:
The reports address the following research questions (RQ):

Report 1: Review of processes (development, dissemination, implementation, sustaining)

    RQ1    How can international best practices, guideline development frameworks, and stakeholder engagement inform the whole DDIS process of an Austrian HEEG to ensure its successful adoption? Which barriers and facilitators exist?

    RQ2    What are the most effective strategies for disseminating the HEEG to key stakeholders (e.g., policymakers, healthcare providers, patients, industry)?

    RQ3    What strategies are needed to ensure the long-term sustainability and continuous use of the HEEG?

    RQ4    How can the impact of the HEEG on reimbursement decisions and healthcare outcomes be monitored and evaluated over time?

Report 2: Guideline content review

    RQ5    What are the key components and methodological standards in international guidelines, and what additional domains are required for a robust and standardised HEEG to be used across all technologies in Austria?

    RQ1    How do existing HEEGs from different countries compare, and what lessons can Austria learn from these frameworks for a nationwide HEEG?

Methods:

Report 1:

§  Conduct a scoping review to explore guideline DDIS processes, good practice frameworks, barriers, facilitators, and stakeholder perspectives related to the DDIS process of the HEEG.

• Map the existing literature, identify key factors, and clarify gaps in knowledge.
• Devise a first DDIS process draft
• Identify Austrian stakeholders and training needs

Report 2:

§  Perform a comparative analysis of HEEGs from selected countries based on existing reviews [3-5, 7]and pharmacoeconomic guidelines [41]

• Identification of common mandatory standards of HEEGs and variations or conflicting themes, such as evaluation type, primary health economic outcome measure, time horizon, sensitivity analysis, discount rate, etc..
• Identification of additional domains, such as HEE methods for AI and complex interventions that may be neglected by standard HEEGs or may become necessary.
• Presentation of choices

§  Initiate a preliminary draft for an Austrian HEEG in the form of a living document.

PICo analysis:

Abbreviations: HEEG…Health economic evaluation guideline, HTA…Health technology assessment, PICo…Problem, Interests, Context

Internal and external reviewers ensure the quality of the documents produced.

Timeline:

References:
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